Label: GOOD CARE STERILE SCRUB BRUSH WITH PCMX - chloroxylenol solution

  • NDC Code(s): 50685-008-00
  • Packager: Dalian Goodwood Medical Care Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

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  • Good Care Sterile Scrub Brush with 3.3% PCMX
  • Active Ingredient

    3.3% Parachlorometaxylenol  Cleansing Solution With Emollient

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  • Purpose

    Antiseptic

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  • Uses

    • For cleansing hands and arms prior to surgery
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  • Warnings

    • For external use only
    • Do not use in eyes

    Stop use and ask a doctor if

    •  skin shows symptoms of irritation, sensitivity, redness, pain or swelling

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control right away
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  • Directions

    • Wet hands and forearms with water
    • Clean under nails with nail cleaner
    • Scrub for 3 minutes with the impregnated brush
    • Pay close attention to the nails, cuticles, and interdigital spaces
    • Rinse thoroughly with running water
    • Repeat
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  • Other Information

    • Store at room temperature
    • Avoid excessive heat above 40 degrees C (104 degrees F)
    • Protect from freezing
    • Latex free
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  • Inactive Ingredients

    Citric Acid, PEG -120 Methyl Glucose Dioleate, Purified Water, Sodium Hydroxide, Sodium Lauroyl Sarcosinate, Sodium Lauryl Sulfate, Sodium Sulfonate, Soya Fatty Acid, Vinylpyrrolidone

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  • Manufactured by Dalian Goodwood Medical Care Ltd.

    Made in China

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  • Good Care Sterile Scrub Brush with 3.3% PCMX (50685-008-00)
  • INGREDIENTS AND APPEARANCE
    GOOD CARE STERILE SCRUB BRUSH WITH PCMX  
    chloroxylenol solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50685-008
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 3.3 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    PEG-120 METHYL GLUCOSE DIOLEATE  
    WATER  
    SODIUM HYDROXIDE  
    SODIUM LAUROYL SARCOSINATE  
    SODIUM LAURYL SULFATE  
    SOYBEAN  
    POLYQUATERNIUM-16 (N-VINYLPYRROLIDINONE:3-METHYL-1-VINYLIMIDAZOLIUM CHLORIDE (5:5))  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50685-008-00 20 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333E 02/13/2013
    Labeler - Dalian Goodwood Medical Care Ltd. (529575699)
    Registrant - Dalian Goodwood Medical Care Ltd. (529575699)
    Establishment
    Name Address ID/FEI Business Operations
    Dalian Goodwood Medical Care Ltd. 529575699 manufacture(50685-008)
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